MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NAVIFLEX RX DELIVERY SYSTEM; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00533560
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.
Event or Problem Description
It was reported to boston scientific corporation that an advanix-naviflex was used to treat a stricture during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.The patient's anatomy was not tortuous.During the procedure, it was noted that the stylet came away from the catheter and it remained inside the patient after the stent was deployed, the catheter was then removed using a rat tooth.The procedure was completed using another of the same device.No patient complications were reported as a result of this event.

• Brand Name: NAVIFLEX RX DELIVERY SYSTEM
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 21114461
• Report Number: 3005099803-2024-06861
• Device Sequence Number: 20698762
• Product Code: FGE
• UDI-Device Identifier: 08714729787082
• UDI-Public: 08714729787082
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K101314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/09/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/02/2026
• Device Model Number: M00533560
• Device Catalogue Number: M00533560
• Device Lot Number: 0033743392
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2024
• Initial Report FDA Received Date: 01/09/2025
• Date Device Manufactured: 04/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown